Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Cartexan (Condrosan)
400 mg, hard capsules
Sodium chondroitin sulfate
Cartexan and Condrosan are different trade names for the same medicinal product.
Please read the following leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If the patient experiences any adverse effects, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Cartexan is and what it is used for
What you need to know before taking Cartexan
How to take Cartexan
Possible side effects
How to store Cartexan
Contents of the pack and other information

1. What Cartexan is and what it is used for

The active substance in Cartexan, sodium chondroitin sulfate, is a naturally occurring substance in
the human body. It is one of the structural components of joint cartilage.
Cartexan is used in the symptomatic treatment of osteoarthritis of the knee and hip joints.
Cartexan has a slow onset of action, with effects beginning within 6 to 8 weeks; therefore, for the treatment of acute or short-term pain, other medications are recommended.
The therapeutic effect usually persists for 2 to 3 months after discontinuation of treatment.
If no improvement occurs or if the patient feels worse, consult a doctor.

2. Important information before taking Cartexan

When not to take Cartexan

if the patient is allergic to chondroitin sulphate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Cartexan, please discuss this with your doctor or pharmacist.

if the patient suffers from heart disease (heart failure) or kidney failure. Cartexan may cause fluid retention and oedema.
if the patient suffers from liver insufficiency.
if the patient is taking medicines affecting blood clotting (such as acetylsalicylic acid, dipyridamole or clopidogrel).
if the patient is taking painkillers, as treatment with chondroitin sulphate may reduce the need for pain-relieving medicines.

Children
Cartexan is not recommended for use in children.
Cartexan and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or plans to take any other medicines. This particularly applies to medicines affecting blood clotting (such as warfarin, acetylsalicylic acid, dipyridamole or clopidogrel).
If the patient is taking warfarin, the doctor may recommend more frequent INR monitoring after starting or stopping treatment with Cartexan.
Cartexan with food and drink
Cartexan can be taken before, during, or after meals. If the patient is prone to stomach problems, the medicine should be taken after a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There is no data available on the use of Cartexan during pregnancy or breastfeeding, and therefore the medicine should not be used during pregnancy or breastfeeding.
Driving and using machines
Cartexan has not been shown to affect the ability to drive or operate machinery.

3. How to take Cartexan

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
Do not chew the capsules; they must be swallowed whole, with an adequate amount of liquid (e.g. a glass of water).
The recommended dose is 800 mg, i.e. 2 capsules as a single daily dose administered for three months.
In more severe cases, the recommended dose is 1200 mg, i.e. 3 capsules per day for the first 4 to 6 weeks of treatment, followed by 800 mg as a single daily dose until the end of the three-month treatment period. The daily dose of 1200 mg may be taken at once or divided into three doses, i.e. 1 capsule three times a day.
Treatment consists of repeated three-month treatment periods with two-month breaks without taking the medicine.
Use in children
Cartexan is not recommended for use in children.
Accidental overdose of Cartexan
One report has been received of accidental or intentional overdose without consequences for the patient (no vomiting, nausea, or changes in blood electrolyte concentrations). Based on studies, harmful effects or symptoms are not expected. In case of overdose, always contact the Toxicology Information Centre (tel. 607 218 174).
Missed dose of Cartexan:
No specific effects are expected. Do not take a double dose to make up for a missed dose; continue treatment by taking the next normal dose on the following day.
Stopping treatment with Cartexan
No specific effects are expected.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects occurring rarely (in up to 1 user in 1,000):
Gastrointestinal disorders: Gastrointestinal disturbances (such as upper abdominal pain, nausea, or
diarrhea).
Skin and subcutaneous tissue disorders: Erythema, papular skin eruptions, irritant dermatitis.
Adverse effects occurring very rarely (in up to 1 user in 10,000):
Skin and subcutaneous tissue disorders: Eczema, skin itching, urticaria. General symptoms: Edema.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the national reporting system: Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of this medicinal product can be collected.

5. How to store Cartexan

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date:". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Cartexan contains

The active substance is sodium chondroitin sulfate. Each hard capsule contains 400 mg of sodium chondroitin sulfate.
Other components: magnesium stearate. The excipients in the capsule shell are gelatin, titanium dioxide, indigo carmine (E 132), and quinoline yellow (E 104).

What Cartexan looks like and contents of the pack
Cartexan hard capsules are available in packs of 24, 60, and 180 hard capsules.
The outer package contains 180 capsules (3 packs of 60).
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Spain, the country of export:
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain

Manufacturer
Noucor Health., S.A.
Avda. Camí Reial, 51-57
08184 Palau-solità i Plegamans (Barcelona)
Spain

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria, Finland, Hungary and Poland - Cartexan
Czech Republic - Condrodin

Spanish Marketing Authorisation Number (country of export): 815241.4
Parallel Import Authorisation Number: 87/26